This Limited Competition Funding
Opportunity Announcement (FOA) invites applications to continue the
activities of the National NeuroAIDS Tissue Consortium (NNTC) Clinical Sites
as previously funded under RFA-MH-13-070.
The NNTC Clinical Sites will function as part of the NNTC, a national
resource that provides clinical data and biological specimens to NeuroAIDS
investigators interested in conducting research toward a cure of Human
Immunodeficiency Virus (HIV-1) infection from the central nervous system
(CNS), and research on the neuropathogenesis of HIV-1 induced CNS and
peripheral nervous system (PNS) dysfunction in the context of anti-retroviral
therapy (ART). The NNTC Clinical Sites collect neuromedical and
neuropsychiatric data from late stage, HIV-1 infected subjects who have
indicated a willingness to participate in organ donation. The NNTC Clinical
Sites are responsible for the following: 1) recruitment, clinical assessment
and follow-up of the late-stage NNTC cohort; and 2) collection, maintenance
and distribution of specimen resources. All data generated from these
activities are transferred to the NNTC Data Coordinating Center
(DCC). The NNTC Clinical Sites work cooperatively with the DCC to
provide the clinical data and specimen resources to research investigators. A
limited competition for the NNTC DCC is being sought under a separate but
related companion FOA (RFA-MH-18-251).

Key Dates

Posted Date

April 19, 2017

Open Date (Earliest Submission Date)

June 26, 2017

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

July 26, 2017, by 5:00 PM local time of applicant
organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.

Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the submission
process by the due date.

Scientific Merit Review

November 2017

Advisory Council Review

January 2018

Earliest Start Date

March 2018

Expiration Date

July 27, 2017

Due Dates for E.O. 12372

Not Applicable

Required
Application Instructions

It is critical that applicants follow the Research (R) Instructions
in the SF424
(R&R) Application Guide, except where instructed to do otherwise (in
this FOA or in a Notice from the NIH
Guide for Grants and Contracts). Conformance to all requirements (both
in the Application Guide and the FOA) is required and strictly enforced. Applicants
must read and follow all application instructions in the Application Guide as
well as any program-specific instructions noted in Section IV. When the program-specific
instructions deviate from those in the Application Guide, follow the
program-specific instructions. Applications that do not comply with
these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

Use the NIH ASSIST system to prepare, submit and track your application online.

Go to Grants.gov to download an application package to complete the application forms offline or create a Workspace to complete the forms online; submit your application to Grants.gov; and track your application in eRA Commons.

This funding opportunity announcement (FOA) is being re-issued
with the aim of supporting the continuation of the NNTC as resource for studies
on the neuropathogenesis of HIV-1 induced CNS and PNS dysfunction in the
context of ART and research towards a cure of HIV-1 infection from the CNS including
studies of viral persistence, latency, reactivation and eradication.

The NNTC is currently comprised of four NNTC Clinical Sites
and one Data Coordinating Center (DCC). The consortium works cooperatively to
provide NeuroAIDS investigators with clinically annotated data sets and with
specimens that have been obtained during life (plasma, CSF, blood); and at
post-mortem (HIV-1 positive brains, HIV-1 negative brains, PNS tissue, heart,
lung, liver, kidney, lymph nodes, blood and cerebral spinal fluid (CSF)). The
NNTC Clinical Sites recruit and manage the NNTC Cohort which is comprised of late
stage HIV-1 positive subjects who are willing to participate in organ donation
and most of whom use ART. The NNTC Clinical Sites perform comprehensive clinical
assessments (neuromedical, neuropsychological, psychiatric and virological data
are collected ante mortem), and then at post mortem, they collect brain and
neurological tissues and fluids, perform neuropathological diagnosis and
laboratory assessments and transfer all data generated from these activities to
the data repository which is maintained by the DCC. Research investigators may
query the available NNTC clinical specimens and data at the NNTC website.

HIV-1 induced neurological dysfunction and HIV-1 persistence
in the CNS continue in people with chronic HIV-1 infection despite suppressive
ART. To provide NeuroAIDS investigators with resources from people who are
surviving chronic HIV-1 disease with ART, the resources of the CNS HIV-1 Antiretroviral
Therapy Effects Research (CHARTER) studies are now fully integrated with the
NNTC. The CHARTER specimens (plasma, CSF, buccal swabs, nucleic acids and
neuroimaging) are maintained by one of the four NNTC Clinical Sites, the
California NeuroAIDS Tissue Network. CHARTER data sets (clinical, laboratory,
genetic, neuroimaging and research) are maintained by the DCC, and external
requests for data or tissues are managed by the DCC in collaboration with the
NNTC Clinical Sites. In affiliation with the DCC, the Global HIV-1 CSF Escape
Consortium has also recently been established. CSF escape is a rare phenomenon
that occurs when rebound viremia is detectable in the CSF of patients despite
ART suppression of the virus in the peripheral blood. Researchers may
contribute their relevant data to the DCC for potential collaborative studies
and participate in on-line forums by contacting the DCC. The specimens from CSF
escape cases are stored at the clinical sites of origin. This funding
opportunity encourages expansion of the existing multi-site brain bank
structure of the NNTC to affiliate the DCC with other national and
international clinical sites that have collected CNS and PNS specimens and
clinical/experimental data. The DCC-affiliated Clinical Sites will contribute
NeuroAIDS data sets. The DCC will manage external requests for the data and the
specimens stored at the affiliated clinical sites or other appropriate
location. This will ensure that NeuroAIDS investigators have access to CNS and
PNS resources that are difficult to obtain from HIV-1 infected individuals
across the lifespan.

The NNTC has defined criteria for a unique subset of HIV-1
positive participants of the NNTC Cohort who were on suppressive ART in life
and who participated in organ donation. Brain and other tissue specimens
from this unique subset of the NNTC repository are entitled, "Virally
Suppressed Cases" (NOT-MH-16-008).
ART suppresses HIV-1 RNA levels in peripheral blood and CSF, yet it does not
completely eliminate the virus. Viral rebound becomes detectable in the
peripheral blood and CSF within weeks when patients cease taking their
anti-retroviral medication. The NNTC successfully documents the neurocognitive
status and last known HIV-1 viral load prior to death for the late-stage NNTC
Cohort. However, ethical and palliative care of individuals often involves
cessation of ART. Brain and fluid samples obtained in combination with
de-identified medical records from donors who die suddenly from other causes
may support neuropathological studies on the mechanisms by which comorbidities
develop in association with neurological complications of chronic HIV-1
disease. Additional brain specimens and clinical data from HIV-1 positive
donors who die suddenly from other causes are also needed to support
researchers involved in determining the cellular and tissue sources of latent
HIV-1 under suppressive therapy. This is critical since latent virus may be a
source of rebound viremia if ART resistance develops in the CNS or upon
cessation of therapy. This FOA encourages identification of additional CNS and
PNS research resources from individuals who are surviving HIV-1 infection with
ART suppression, yet die suddenly from other causes.

The key consortium wide objectives for this and the
companion FOA, RFA-MH-18-251,
are to ensure that NNTC CNS and PNS tissues/fluids and data are available and
useful to investigators for examining emerging topics in the NeuroAIDS field
such as research: a) towards a cure of HIV-1 infection from the CNS including
studies of viral persistence, latency, reactivation and eradication in the
context of ART; b) on neuropathogenic mechanisms of HIV-1 induced neurological
dysfunction in the setting of ART; and c) on understanding comorbidities
associated with HIV-1 induced neurological dysfunction including aging with
chronic HIV-1 disease. Through these two FOAs, the NIH expects to continue
to fund up to four NNTC Clinical Sites (RFA-MH-18-250)
and one Data Coordinating Center (RFA-MH-18-251).

NNTC Clinical Sites Objectives

The key objective for this FOA is to pursue the continued
operations of the NNTC Clinical Sites. The NNTC Clinical Sites are responsible
for the following activities of the consortium: 1) recruitment, clinical
assessment and follow-up of the late-stage NNTC Cohort; 2) collection and
maintenance of ante mortem and post mortem specimens along with
neuropathological and laboratory analysis of specimens; 3) collection,
de-identification and quality control assessment of data sets; 4) rapid
transfer of all data sets affiliated with the NNTC Clinical Sites to the DCC
including clinical, laboratory and inclusion of a specimen inventory of all
tissue and fluid specimens collected and housed at the clinical sites; 5) distribution
of CNS and PNS tissue and fluid resources to approved NeuroAIDS investigators;
and 6) effective collaboration with the DCC, and other clinical sites
affiliated with the NNTC, to provide CNS and PNS specimen and data resources to
approved investigators engaged in NeuroAIDS research.

This FOA encourages the use of the following common,
standardized approaches for the NNTC Clinical Site activities: clinical
assessment measures, protocols and a database system to rapidly exchange high
quality data sets with the DCC. Such a standardized, high quality repository of
NeuroAIDS specimens and data will enable multidisciplinary query capabilities
and tools to accelerate discovery research on the neuropathogenesis of HIV-1
induced CNS and PNS dysfunction in the context of ART, and CNS-based HIV-1 cure
research.

Recruitment strategies used to selectively enhance the
recruitment of HIV-1 infected subjects into the NNTC Clinical Site cohort
should be responsive to the evolving research needs of investigators for CNS
and PNS tissue, fluids and data sets. The needs of NeuroAIDS investigators for
research resources may be identified and informed by the scope of prior requests
for NNTC resources, statistical and epidemiological analysis of the NNTC
database by the DCC and the state of the science. This FOA encourages development
of recruitment strategies to enhance the NNTC Cohort to help address the
following research areas of high priority to the NIH: a) curing HIV-1 infection
in the CNS, including studies of viral persistence, latency, reactivation and
eradication in the context of ART; b) understanding neuropathogenesis of HIV-1
induced CNS and PNS dysfunction in the context of ART; and c) understanding comorbidities
associated with HIV-1 induced neurological dysfunction including aging with
chronic HIV-1 disease.

Protections
for Human Subjects: Applications with data collection plans
that involve multiple respondent groups (e.g., clients/patients,
therapists/providers, supervisors, administrators) should address provisions
for human subject protections and consenting procedures for all participant
groups, accordingly. Clinical research policies, guidance, and resources can
be found on the NIMH Clinical. Research website: http://www.nimh.nih.gov/funding/clinical-research/index.shtml.

Cooperative Agreement: A support mechanism used when there
will be substantial Federal scientific or programmatic involvement.
Substantial involvement means that, after award, NIH scientific or program
staff will assist, guide, coordinate, or participate in project activities. See
Section VI.2 for additional information about the substantial involvement for
this FOA.

Application Types Allowed

Renewal

The OER
Glossary and the SF424 (R&R) Application Guide provide details on
these application types.

Funds Available and Anticipated Number of Awards

NIMH and NINDS intend to commit approximately $3.1 million
in FY 2018 to fund 4 awards

Although the financial plans of NIMH and NINDS provide
support for this program, awards pursuant to this funding opportunity are
contingent upon the availability of funds. Funding beyond the first year will
be contingent upon satisfactory progress during the preceding years and
availability of funds.

Award Budget

The application budget for each NNTC Clinical Site is
capped at $775,000 per year direct cost.

Award Project Period

The total project period for an
application submitted in response to this FOA may not exceed five years.

NIH grants policies as
described in the NIH
Grants Policy Statement will apply
to the applications submitted and awards made in response to this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

The competition for this FOA is being limited to the current
awardees of the National NeuroAIDS Tissue Consortium Clinical Sites (U24),
funded under RFA-MH-13-070.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible
to apply.
Foreign components, as defined in
the NIH Grants Policy Statement, are not allowed.

Required
Registrations

Applicant
Organizations

Applicant organizations must complete and maintain the
following registrations as described in the SF 424 (R&R) Application Guide
to be eligible to apply for or receive an award. All registrations must be
completed prior to the application being submitted. Registration can take 6 weeks
or more, so applicants should begin the registration process as soon as
possible. The NIH
Policy on Late Submission of Grant Applications states that failure to
complete registrations in advance of a due date is not a valid reason for a
late submission.

Dun and Bradstreet
Universal Numbering System (DUNS) - All registrations require that
applicants be issued a DUNS number. After obtaining a DUNS number, applicants
can begin both SAM and eRA Commons registrations. The same DUNS number must be
used for all registrations, as well as on the grant application.

System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least
annually. The renewal process may require as much time as the
initial registration. SAM registration includes the assignment of a Commercial
and Government Entity (CAGE) Code for domestic organizations which have not
already been assigned a CAGE Code.

eRA Commons - Applicants
must have an active DUNS number and SAM registration in order to complete the
eRA Commons registration. Organizations can register with the eRA Commons as
they are working through their SAM or Grants.gov registration. eRA Commons
requires organizations to identify at least one Signing Official (SO) and at
least one Program Director/Principal Investigator (PD/PI) account in order to
submit an application.

Grants.gov – Applicants
must have an active DUNS number and SAM registration in order to complete the
Grants.gov registration.

Program
Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.
PD(s)/PI(s) should work with their organizational officials to either
create a new account or to affiliate their existing account with the applicant
organization in eRA Commons. If the PD/PI is also the organizational Signing Official,
they must have two distinct eRA Commons accounts, one for each role. Obtaining
an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal
Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping
applications under review at the same time. This means that the NIH will
not accept:

A new (A0) application that is submitted before issuance of the
summary statement from the review of an overlapping new (A0) or resubmission
(A1) application.

A resubmission (A1) application that is submitted before issuance
of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another
application pending appeal of initial peer review (see NOT-OD-11-101).

Section IV. Application and Submission Information

1. Requesting an
Application Package

Buttons to access the online ASSIST system or to download
application forms are available in Part
1 of this FOA. See your administrative office for instructions if you plan
to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Research (R) Instructions
in the SF424
(R&R) Application Guide, including Supplemental
Grant Application Instructions except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:

All page limitations described in the SF424 Application
Guide and the Table of
Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in
the SF424 (R&R) Application Guide and should be used for preparing an
application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide
must be followed.

R&R Budget

All instructions in the SF424 (R&R) Application Guide
must be followed.

NNTC
Clinical Sites

Due to the complexity and time required to maintain a
well-coordinated, communicative and productive research effort, a minimum
effort of 3.6 person months effort to NNTC Clinical Site activities including
the combined effort of potential multiple PI(s)/PD(s) is required by this FOA.

Annual
Meetings

The PD(s)/PI(s) of the NNTC Clinical Sites are expected to
attend an annual meeting of the NNTC Steering Committee (SC) in the Washington
D.C. area, or another agreed upon locality. The meeting will also be
planned and attended by the PD(s)/PI(s) of the DCC and any delegates of the DCC
PD(s)/PI(s). Applicants to this FOA should include travel to the annual
meeting in their proposed budget, which should include travel for themselves
and a Scientific Advisor (SA). (See Section VI.2. Cooperative Agreement Terms
and Conditions of Award).

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

Specific Aims

Each Clinical Site should articulate a plan for continuing
resource operations including patient assessments, tissue collections,
integration with the DCC, and novel recruitment strategies for enhancement of
the NNTC Cohort to meet the emerging needs of NeuroAIDS investigators engaged
in research.

Research
Strategy

Complete applications will address each of the following
components divided into the following sections with the designated page limits:

1. NNTC Overview

2. Clinical Site Functions and Operating Procedures

3. Clinical Site Collaboration with the DCC

1.
NNTC Clinical Site Overview

Background and Experience. Describe the
clinical site in relation to the NNTC and the experience of the site in
providing CNS and PNS research resources to NeuroAIDS investigators.

Organizational Structure.Describe the
governance of the clinical site in relation to the NNTC including the role of the
team in responding to cohort changes and the changing needs of NeuroAIDS investigators
for CNS and PNS resources.

Catchment Area. Describe the size and
unique characteristics of the patient population in relation to the HIV-1
epidemic, the site cohort and enrollment goals to recruit and follow-up with
site cohort participants.

Progress. Describe the progress of the site
in recruiting, enrolling and following-up with NNTC cohort participants.
Describe the site progress in acquiring tissue and fluid specimens from HIV-1
positive and negative individuals ante mortem, and post mortem autopsies
delineating in-study and donations. Describe the site progress in providing
neuropsychological, neuropathological and laboratory analysis, and supporting
utilization of resources by NeuroAIDS investigators. Describe the site
contributions to collaborative activities within the NNTC including effective
collaboration with the DCC to provide quality controlled, de-identified
clinical data to the DCC.

2.
Clinical Site Functions and Operating Procedures

Applicants should provide the following details:

Describe how the site will follow standard NNTC clinical and
laboratory protocols, specimen collection protocols and data
acquisition/quality control and quality assessment protocols.

Describe all site specific assessments that are not included in
the NNTC protocols.

Describe the recruitment and retention strategies and unique
strengths of the site to enhance recruitment. While applicants should describe
their enrollment plans in their applications, the final determination of the
enrollment criteria for the sites will be determined by Steering Committee (SC)
and NIH.

Describe how the site will fully participate in SC activities
including contributing to the agenda, work group activities, conference calls,
teleconferences and attendance at the annual meeting.

Provide a description of the overall strategy and operational
plan including a timeline and plan for the work-flow at the Clinical Site. Include
a description of the communications and organizational structure of the
Clinical Site and describe any cooperative administrative arrangements involved
if multiple institutions will be involved with the site.

Describe how the specific site will contribute to and enhance the
overall goals and operational goals of the Consortium.

Describe plans to include a Scientific Advisor (SA) on the study
team, preferably one who is not directly associated with the NNTC institutions
and who can bring a broad and independent perspective to the NNTC.

Describe quality control and quality assurance measures for the data,
laboratory and the clinic.

Describe how the site will facilitate access to care for HIV-1
infected patients.

Define the process that the site will use to contribute to the
current NNTC standardized assessments of neurocognitive, neurobehavioral, and
other clinical status, laboratory assessments and specimen collections; include
potential cost containment procedures for the structure, timing and content of tiered
subject visits along with a description of the cohort structure.

Describe how the site will address between-site differences in
the subjects recruited and retained within the NNTC Cohort (demographics,
language, recruitment number, length of patient enrollment and follow up), and
how the site differences integrate into the Consortium.

Discuss how collaboration and synergy with other sites will be
fostered and maintained; discuss how the specific-site will interact with the
NNTC SC and the DCC (See Section VI. 2 Cooperative Agreement Terms and
Conditions of Award.); describe intra-site communication and decision-making
practices. Each Clinical Site PD(s)/PI(s) should address how they will actively
assume the responsibility and remain engaged with all SC activities and issues.

3.
Clinical Site Collaboration with the DCC

To fully collaborate as a Consortium and encourage
capabilities as an integrated repository of NeuroAIDS data and specimens,
applications are expected to address the following:

Detail site plans for seamless and timely collaboration with the
DCC and other clinical sites affiliated with the Consortium.

Describe the role and responsibilities of the site to ensure
transfer of the clinical, specimen and site-specific specimen inventory data to
the DCC including the following: data configuration requirements, checks for
quality control/quality assessments, timelines to respond to DCC Data Audit and
Site Visit reports and timelines for rapid sharing of data with the DCC,
consistent with achieving the goals of the program.

Describe the site plan and timeline for ensuring transfer of all NNTC-affiliated data
to the DCC for storage in the NNTC database and query by NeuroAIDS
investigators. The plan should include all data collected from NNTC clinical sites including assessments and in-clinic
interviews, results from telephone interviews, specimen annotations and
laboratory data.

Describe plans to provide the DCC a site-specific Specimen
Inventory and timelines to update the DCC with new information.

Detail plans for maintaining the NNTC clinical database with a
data dictionary which reflects the state of the science and nomenclature for
the field of NeuroAIDS.

Detail the process to be implemented by the site to respond to
requests from investigators for research resources. Provide a timeline for
response to the DCC after initial broadcast of the request and the timeline to
ship specimens once approved.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans as provided in the SF424 (R&R)
Application Guide, with the following modification:

It is expected that applications will include plans for
interactions with the other NNTC Clinical Sites and the DCC as well as other
relevant ongoing studies of NeuroAIDS within the NNTC to maximize investments
and further standardization and sharing across projects.

All applications, regardless of the amount of direct costs
requested for any one year, should address an individual Resource Sharing Plan which
will then be incorporated into a consortium wide NNTC Resource Sharing Plan
prior to award, consistent with achieving the goals of the program. For this
FOA and the companion FOA (RFA-MH-18-251), the PD(s)/PI(s) of the NNTC Clinical
Sites and DCC will collaborate with NIMH during the pre-award period to develop
a consortium wide NNTC Resource Sharing Plan that will specify criteria for
access to specimens, de-identified data, conditions for research use, and
procedures and timelines for vetting requests for access to data maintained by
the PD(s)/PI(s) of the NNTC Clinical Sites and the DCC. The consortium-wide
NNTC Resource Sharing Plan and other Just-In-Time information are required
prior to award. The applicant should propose a resource sharing plan in the
application that takes this expectation into account.

Applications should include information on the data dictionary,
type and descriptors of data to be shared (i.e., clinical protocols and data,
laboratory and research data sets), as well as a timeline for the site to reach
consensus on neuropathology and neurocognitive status once the assessments are
completed and a plan for data quality control, coordination, standardization,
access privileges, and the schedule and timeline for release of data (time from
acquisition to release to the NNTC DCC), consistent with achieving the goals of
the program.

Describe how the data from the site should be made available to
the research community through publications, or public website, consistent with
achieving the goals of the program.

Describe the procedure to be followed in the event that
participants withdraw consent to share their individual-level data (i.e., the
timeframe and procedure for alerting the NNTC DCC to request that the specific
research participant’s data should be removed from future data distributions).
Should individuals previously consented by the NNTC clinical site request
removal from future data distribution include a description of the procedures
the site will follow to comply.

Include plans for maintenance, or transfer of ownership of
the NNTC specimens and on-site NNTC-affiliated data set and database if they
are to be stored beyond the funding period, as appropriate and consistent with
achieving the goals of the program.

Appendix:

Do
not use the Appendix to circumvent page limits. Follow all instructions for the
Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report

When conducting clinical research, follow all instructions
for completing PHS Inclusion Enrollment Report as described in the SF424
(R&R) Application Guide.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide
must be followed.

3. Unique Entity Identifier
and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the
requirement for obtaining a unique entity identifier and for completing and
maintaining active registrations in System for Award Management (SAM), NATO
Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and
Grants.gov

4. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to
submit applications before the due date to ensure they have time to make any
application corrections that might be necessary for successful submission. When
a submission date falls on a weekend or Federal
holiday, the application deadline is automatically extended to the next
business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants
across all Federal agencies). Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration. NIH and Grants.gov systems check the application against many
of the application instructions upon submission. Errors must be corrected and a
changed/corrected application must be submitted to Grants.gov on or before the application
due date and time. If a Changed/Corrected application is submitted after the
deadline, the application will be considered late. Applications that miss the
due date and time are subjected to the NIH Policy on Late Application
Submission.

Applicants
are responsible for viewing their application before the due date in the eRA
Commons to ensure accurate and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically. If you encounter a system issue beyond your control that
threatens your ability to complete the submission process on-time, you must
follow the Guidelines
for Applicants Experiencing System Issues. For assistance with application
submission, contact the Application Submission Contacts in Section VII.

Important
reminders:

All PD(s)/PI(s) must include their eRA Commons ID in
the Credential fieldof the Senior/Key Person Profile Component of the
SF424(R&R) Application Package. Failure to register in the Commons
and to include a valid PD/PI Commons ID in the credential field will prevent
the successful submission of an electronic application to NIH. See Section III of this FOA for information on
registration requirements.

The applicant organization must ensure that the DUNS
number it provides on the application is the same number used in the
organization’s profile in the eRA Commons and for the System for Award Management.
Additional information may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness and compliance with application instructions by the Center for
Scientific Review and responsiveness by components
of participating organizations, NIH. Applications that are incomplete, non-compliant
and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in the policy.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact

Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the project to exert a sustained,
powerful influence on the research field(s) involved, in consideration of the
following review criteria and additional review criteria (as applicable for the
project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance

Does the proposed Project address
the needs of the research project that it will serve? Is the scope of
activities proposed for the Project appropriate to meet those needs? Will
successful completion of the aims bring unique advantages or capabilities to
the research resource?

Investigator(s)

Are the PD(s)/PI(s) and other
personnel well suited to their roles in the Project? Do they have appropriate
experience and training, and have they demonstrated experience and an ongoing
record of accomplishments in managing CNS and PNS resources for NeuroAIDS
research? Do the investigators demonstrate significant experience with
coordinating collaborative basic research? If the Project is multi-PD/PI, do
the investigators have complementary and integrated expertise and skills; are
their leadership approach, governance, plans for conflict resolution, and
organizational structure appropriate for the Project? Does the applicant have
experience overseeing selection and management of sub awards, if needed? Are
there key personnel in place to conduct NNTC Clinical Site operations ranging
from community outreach, recruitment, enrollment and retention, clinical exams,
tissue banking, autopsy, pathology, general study design and analysis, on-site
computer expertise for database management, transfer of high quality data to
the DCC and response to DCC data audits?

Innovation

Does the application propose novel
organizational concepts in coordinating the research resource the Project will
serve? Are the concepts or strategies novel to one type of research program or
applicable in a broad sense? Is a refinement, improvement, or new application
of management strategies proposed? Do the applicants present innovative
recruitment strategies for enhancement of the NNTC Cohort to fulfill the
resource needs of investigators engaged in NeuroAIDS research? Are the site
clinical, laboratory, and banking plans innovative?

Approach

? Are the overall strategy, operational plan, and
organizational structure well-reasoned and appropriate to accomplish the goals
of the research resource the Project will serve? Will the investigators promote
strategies to ensure a robust and unbiased scientific approach across the
resource, as appropriate for the work proposed? Are potential problems,
alternative strategies, and benchmarks for success presented? Are an
appropriate plan for work-flow and a well-established timeline proposed? Have
the investigators presented adequate plans to ensure consideration of relevant
biological variables, such as sex, for studies of human subjects? Has the site
planned sufficient time to ensure appropriate oversight? Are the recruitment
strategies for the end-stage NNTC Cohort feasible given the size and make-up of
the cohort? Are the clinical plans for recruiting and maintaining the cohort
and resource management financially feasible and well-coordinated with other
NNTC Clinical Sites and the DCC? Does the site propose an organizational
structure that facilitates collaboration with the DCC, the other NNTC Clinical
Sites, and research investigators? If multiple institutional sites are involved
does the application include a detailed description of the cooperative
administrative arrangements?

Environment

Will the institutional
environment in which the Project will operate contribute to the probability of
success in facilitating the research resource it serves? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the Project proposed? Will the Project benefit from unique
features of the institutional environment, infrastructure, or personnel? Are
resources available within the scientific environment to support electronic
information handling?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact score, but will not give
separate scores for these items.

Protections for Human Subjects

For research that involves human
subjects but does not involve one of the six categories of research that are
exempt under 45 CFR Part 46, the committee will evaluate the justification for
involvement of human subjects and the proposed protections from research risk
relating to their participation according to the following five review
criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential
benefits to the subjects and others, 4) importance of the knowledge to be
gained, and 5) data and safety monitoring for clinical trials.

For research that involves human
subjects and meets the criteria for one or more of the six categories of
research that are exempt under 45 CFR Part 46, the committee will evaluate: 1)
the justification for the exemption, 2) human subjects involvement and
characteristics, and 3) sources of materials. For additional information on
review of the Human Subjects section, please refer to the Guidelines for the Review of Human
Subjects.

Inclusion of Women, Minorities,
and Children

When the proposed project involves
human subjects and/or NIH-defined clinical research, the committee will
evaluate the proposed plans for the inclusion (or exclusion) of individuals on
the basis of sex/gender, race, and ethnicity, as well as the inclusion (or
exclusion) of children to determine if it is justified in terms of the
scientific goals and research strategy proposed. For additional information on
review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion
in Clinical Research.

Vertebrate Animals

The committee will evaluate the
involvement of live vertebrate animals as part of the scientific assessment
according to the following criteria: (1) description of proposed procedures
involving animals, including species, strains, ages, sex, and total number to
be used; (2) justifications for the use of animals versus alternative models
and for the appropriateness of the species proposed; (3) interventions to
minimize discomfort, distress, pain and injury; and (4) justification for
euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia
of Animals. Reviewers will assess the use of chimpanzees as they would any
other application proposing the use of vertebrate animals. For additional
information on review of the Vertebrate Animals section, please refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether
materials or procedures proposed are potentially hazardous to research
personnel and/or the environment, and if needed, determine whether adequate
protection is proposed.

Resubmissions

Not Applicable

Renewals

For Renewals, the committee will
consider the progress made in the last funding period.

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact score.

Applications from Foreign
Organizations

Not Applicable

Select Agent Research

Reviewers will assess the
information provided in this section of the application, including 1) the
Select Agent(s) to be used in the proposed research, 2) the registration status
of all entities where Select Agent(s) will be used, 3) the procedures that will
be used to monitor possession use and transfer of Select Agent(s), and 4) plans
for appropriate biosafety, biocontainment, and security of the Select Agent(s).

For projects involving key biological and/or chemical resources,
reviewers will comment on the brief plans proposed for identifying and ensuring
the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the
budget and the requested period of support are fully justified and reasonable
in relation to the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by NIMH, in
accordance with NIH peer
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications:

Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in
response to this FOA.

Applications will be assigned on the basis of established
PHS referral guidelines to the appropriate NIH Institute or Center. Applications
will compete for available funds with all other recommended applications submitted
in response to this FOA. Following initial peer review, recommended applications
will receive a second level of review by the National Advisory Mental Health
Council . The following will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons. Refer to Part 1 for dates for peer review, advisory council
review, and earliest start date.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA)
will be provided to the applicant organization for successful applications. The
NoA signed by the grants management officer is the authorizing document and
will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described
in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be
subject to terms and conditions found on the Award
Conditions and Information for NIH Grants website. This includes any
recent legislation and policy applicable to awards that is highlighted on this
website.

Recipients of federal financial
assistance (FFA) from HHS must administer their programs in compliance with
federal civil rights law. This means that recipients of HHS funds must ensure
equal access to their programs without regard to a person’s race, color,
national origin, disability, age and, in some circumstances, sex and religion.
This includes ensuring your programs are accessible to persons with limited
English proficiency. HHS recognizes that research projects are often limited
in scope for many reasons that are nondiscriminatory, such as the principal
investigator’s scientific interest, funding limitations, recruitment
requirements, and other considerations. Thus, criteria in research protocols
that target or exclude certain populations are warranted where
nondiscriminatory justifications establish that such criteria are appropriate
with respect to the health or safety of the subjects, the scientific study
design, or the purpose of the research.

For additional guidance regarding how the provisions apply
to NIH grant programs, please contact the Scientific/Research Contact that is
identified in Section VII under Agency Contacts of this FOA. HHS provides
general guidance to recipients of FFA on meeting their legal obligation to take
reasonable steps to provide meaningful access to their programs by persons with
limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html.
The HHS Office for Civil Rights also provides guidance on complying with civil
rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html;
and http://www.hhs.gov/ocr/civilrights/understanding/index.html.
Recipients of FFA also have specific legal obligations for serving qualified
individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
Please contact the HHS Office for Civil Rights for more information about
obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS
Departmental goal to ensure access to quality, culturally competent care,
including long-term services and supports, for vulnerable populations. For
further guidance on providing culturally and linguistically appropriate
services, recipients should review the National Standards for Culturally and
Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in
Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal
Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal
Awardee Performance and Integrity Information System (FAPIIS) requirements.
FAPIIS requires Federal award making officials to review and consider
information about an applicant in the designated integrity and performance
system (currently FAPIIS) prior to making an award. An applicant, at its
option, may review information in the designated integrity and performance
systems accessible through FAPIIS and comment on any information about itself
that a Federal agency previously entered and is currently in FAPIIS. The
Federal awarding agency will consider any comments by the applicant, in
addition to other information in FAPIIS, in making a judgement about the
applicant’s integrity, business ethics, and record of performance under Federal
awards when completing the review of risk posed by applicants as described in
45 CFR Part 75.205 “Federal awarding agency review of risk posed by
applicants.” This provision will apply to all NIH grants and cooperative
agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and
not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB)
administrative guidelines, U.S. Department of Health and Human Services (DHHS)
grant administration regulations at 45 CFR Part 75and other HHS, PHS, and NIH
grant administration policies.

The administrative and funding instrument used for this program will be the
cooperative agreement, an "assistance" mechanism (rather than an "acquisition"
mechanism), in which substantial NIH programmatic involvement with the awardees
is anticipated during the performance of the activities. Under the cooperative
agreement, the NIH purpose is to support and stimulate the recipients' activities
by involvement in and otherwise working jointly with the award recipients in a
partnership role; it is not to assume direction, prime responsibility, or a
dominant role in the activities. Consistent with this concept, the dominant
role and prime responsibility resides with the awardees for the project as a
whole, although specific tasks and activities may be shared among the awardees
and the NIH as defined below.

The
NNTC Clinical Site PD(s)/PI(s) have the following primary responsibilities:

Committing at least 3.6 person months effort (including the
combined effort of potential multiple PI(s)/PD(s)) to: overseeing site-specific
clinical assessment, specimen banking including the CHARTER resources and brain
pathology/specimen laboratory testing activities including follow-up of
subjects to determine disease outcomes; ensuring that informed consent has been
conducted appropriately; fully participating in Consortium wide activities
including the Steering Committee (SC) meetings, work group meetings, and teleconferences
and contributing to the determination of the agenda for the annual SC meeting.

Implementing the NNTC recruitment strategy at the Clinical Site
to inform the selective enhancement of the NNTC Cohort and ensure the strategy
for recruitment is responsive to the research resource needs of investigators;

Ensuring adherence to the following NNTC SC approved protocols:
clinical assessment anti mortem, laboratory analysis of specimens and autopsy
and storage of the specimen resources according to NNTC standard operating
procedures.

Providing yearly progress reports which will include: each site
should include their progress in meeting their targeted enrollment and
recruitment goals for the prior year by providing a table to demonstrate the
following information: 1) the annual change in cohort recruitment and retention
including a table of the total number of cohort participants at the site
including their demographics, tier status and whether they are HIV-1 positive
or negative; 2) the newly enrolled recruit-to-replace participants for the
prior year including their demographics, tier status and whether they are HIV-1
positive or negative; 3) the number of the NNTC cohort participants retained,
lost to follow up or autopsied in the prior year and indicate whether the
autopsies performed in the prior year were a) conducted on HIV-1 positive
verses negative subjects; b) conducted on subjects enrolled in the NNTC study
or were donated to the NNTC study; c) for autopsies conducted on-study indicate
the number of ante mortem clinical assessments prior to post mortem. Each site
should also include other accomplishments including the number of requests for
resources that have been received, a list of the number and types of resources
shipped to the investigators, the current specimen inventory, a list of
publications, articles in press, manuscripts in preparation, and abstracts.

Rapidly sharing quality controlled NNTC-related clinical data and
specimen inventories with the DCC, updating the clinical data and specimen
inventory within two months of data collection. Providing prompt responses to
requests from investigators for NNTC-related research resources. Address any
lapses in data transfer from the Clinical Site to the DCC according to the
guidelines set up by the SC and communicate these lapses to NIH Program Staff
within two months. NIH reserves the right to restrict funds to any NNTC
clinical site on a semi-annual basis for failure to comply with the data
sharing goals of the Consortium.

Using methodologies determined by the DCC (in collaboration with
the SC) and in accordance with the NNTC data sharing plan, provide all clinical data,
specimen annotation data, and NNTC-related research data to the DCC.

Ensure rapid sharing of clinical, laboratory and research data
and associated clinical CNS and PNS specimens according to the schedule and
timeline agreed upon in the NNTC Data Sharing Plan.

Retaining custody of and having primary rights to the data and
software developed under these awards, subject to Government rights of access
consistent with current DHHS, PHS, and NIH policies.

NIH
staff have substantial programmatic involvement that is above and beyond the
normal stewardship role in awards, as described below:

Project
Scientist:

The NIMH will appoint a Project Scientist (PS). Only the
NIMH PS will have substantial scientific/programmatic involvement during the
conduct of this activity through technical assistance, advice and coordination
above and beyond normal program stewardship for grants or cooperative
agreements. The NIMH PS will be responsible for:

Participating as a voting member of the NNTC SC.

Contributing to the post award design.

Monitoring study results and quality assurance across all sites.

Reviewing all study protocols and data.

Overseeing the collection, storage, and inventory along with
cataloging of clinical specimens.

Creating reports from the NNTC data for use in internal reports.

Program Officer:

One program official from NIMH will be the assigned program
officer on the cooperative agreement applications and will work closely with a
program director from NINDS. Jointly, the two will be responsible for the
normal scientific and programmatic stewardship of the award and will both be named
in the award notice.

Areas
of Joint Responsibility include:

Members of the NNTC Steering Committee (SC) include the
following: NIH Program Officers and NIMH Project Scientist; the PD(s)/PI(s) of
each grant award, or a designated representative in the case of a multiple PI
award; and one Scientific Advisor (SA) from each clinical site. The Data
Coordinating Center PD(s)/PI(s) (DCC PI), or a delegate of the DCC PI, will
serve as Chair of the SC (SC Chair). Voting members will consist of each Clinical
Site PD(s)/PI(s), the DCC PI or the delegate, the SC Chair (if different from
the DCC PI), and the NIMH Project Scientist (NIMH PS). In the case of
multiple-PD(s)/PI(s) or in the case of a delegate of the DCC PI serving as SC
Chair, consensus should be reached among those PD(s)/PI(s) in casting a single
vote. Decisions of the SC will be accepted by all members. The SC has the
following responsibilities:

Implementing the Consortium objectives at the Clinical Sites and
updating these as needed especially in regards to updated factors for selecting
subjects into the NNTC Cohort.

Ensuring the continued allocation of the CHARTER study resources.

Ensuring overall operations and directions of the NNTC are in
keeping with very high standards, ensuring systematic assessment of priorities
and timelines, suggesting improvements to the selection of the existing cohort,
providing guidance on how best to accomplish quality control of clinical
specimens and data, and promoting the utilization of NNTC specimens and data
resources.

Establishing and maintaining collaborative relationships that
facilitate the Consortium’s objectives. These relationships include those
between the Clinical Site investigators, the Steering Committee members,
patient communities, the staff at the NIH institutes that are funding the NNTC,
and other research communities relevant to goals of the Consortium.

Establishing clear data sharing guidelines for the Consortium to
ensure rapid transfer of all quality controlled data and specimen inventories
to the DCC. Lapses in data transfer from the Clinical Site to the DCC that are
longer than two months after data collection should be communicated to the SC
in a timely manner. NIH reserves the right to restrict funds on a
semi-annual basis for failure to comply with the data sharing timelines of the
Consortium.

Conducting an annual, full-day meeting of the SC. The meeting
will be convened in the greater Washington, DC area, or other convenient
location. These meetings are intended to: identify new areas of collaboration
among the Consortium; decide scientific policy; address organizational issues
concerning implementation and oversight of selective recruitment of the NNTC
Cohort; identify gaps in the available research resources; determine the need for
and memberships on working groups; and discuss issues regarding publications,
access to data, interim data monitoring, and investigator access to clinical
specimens and data sets. The focus of the meetings will also include:
determining how the scientific and technical expertise, facilities, and other
resources of the NNTC can contribute to ongoing or new projects; and sharing of
data. PD(s)/PI(s) will also be expected to present their progress and
discuss future strategic plans for the Consortium.

Specifying the guidelines and procedures for the Consortium
including: (1) the timely approval of requests for biological specimens,
clinical data, mining of NNTC datasets, analytical assistance provided by the
NNTC, and access to NNTC-related research data; (2) the timely shipment of
clinical specimens to approved requestors including careful consideration to
releasing specimens at risk of depletion from the NNTC tissue banks and
coordinating shipments of specimens to domestic and foreign countries (i.e., meeting
local and international shipping regulations and laws; assuring sample
integrity for extended shipment), and following up on receipt of sample
delivery along with investigator feedback; (3) contributing to the
establishment and maintenance of a NNTC specimen inventory to be administered
by the DCC; (4) monitoring adherence to informed consent procedures including
the signatures of the NNTC participants; (5) reviewing all NNTC-related
policies and documents in the first 6 months of the funding cycle, and making
amendments if necessary; (5) notifying NNTC-affiliated investigators to include
a Human Subjects Section if they incorporate use of NNTC resources into an NIH
grant application, or if they meet the definition of an investigator in the
recipient's research.

The timely dissemination of study results to the communities
involved is strongly emphasized.

Access
to Data and Specimens

In view of the importance of biological specimens and data,
a detailed specimen inventory including the number and types of biological
specimens and clinical data should be reported to the DCC by the NNTC Clinical
Sites. All requests for access to and/or release of NNTC-related specimens
and/or data, whether from investigators internal or external to the NNTC,
should include a detailed description of the study for which specimens are
sought and the number and volume of specimens requested. Such requests should
be made in accordance with a standardized NNTC Data and Specimen request form
which is provided to the SC for consideration. Prior to approval and release of
specimens and/or data, research plans submitted to the SC will be evaluated to
determine appropriate procedures are in place for any additional human or vertebrate
animal work.

Dispute
Resolution

Any disagreements that may arise in scientific or
programmatic matters (within the scope of the award) between award recipients
and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel
composed of three members will be convened. It will have three members: a
designee of the NNTC SC chosen without NIH staff voting, one NIH designee, and
a third designee with expertise in the relevant area who is chosen by the other
two; in the case of individual disagreement, the first member may be chosen by
the individual awardee. This special dispute resolution procedure does not
alter the awardee's right to appeal an adverse action that is otherwise
appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS
regulation 45 CFR Part 16.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH
Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH
Grants Policy Statement for additional information on this reporting
requirement.

In accordance with the regulatory requirements provided at
45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have
currently active Federal grants, cooperative agreements, and procurement
contracts from all Federal awarding agencies with a cumulative total value
greater than $10,000,000 for any period of time during the period of
performance of a Federal award, must report and maintain the currency of
information reported in the System for Award Management (SAM) about civil,
criminal, and administrative proceedings in connection with the award or
performance of a Federal award that reached final disposition within the most
recent five-year period. The recipient must also make semiannual disclosures
regarding such proceedings. Proceedings information will be made publicly
available in the designated integrity and performance system (currently
FAPIIS). This is a statutory requirement under section 872 of Public Law
110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public
Law 111-212, all information posted in the designated integrity and performance
system on or after April 15, 2011, except past performance reviews required for
Federal procurement contracts, will be publicly available. Full reporting
requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award
Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.